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Completed

NCT Number: NCT02740738

Preoperative Pain Threshold and Rapid Recover Programs

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

About this study

A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory.

Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection.

  • This is initially performed once on ipsilateral the tibialis anterior as a "warm up."
  • Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score.
  • Lastly, three measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient.
  • Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.

Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit.

Postoperative, the study team will ask the participant at the 6 week mark:

  • How many and what kind of opiates did the participant require?
  • How many days did the participant require opiates?
  • Did the participant require a refill? a. If so, did the participant have this filled in clinic preemptively or place a phone call to the office?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
  • Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler

Exclusion criteria

  • previous hip or knee surgery in the operative joint

Treatment and study plan

Wagner Pain Algometer

Device

applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds

Dynamometer

Device

Dominant Hand Grip strength measured by the average of 3 attempts

Primary outcomes

  1. Inpatient length of stay in days

    Time frame: 1-3 on days average

    amount of time in hospital

  2. pain control average visual analogue scale 1 - 10 of hospital stay

    Time frame: 1-3 days on average

    averaging the subjective pain control

  3. physical therapy performance on the first day after surgery

    Time frame: post op day 1

    distance walked in feet on post op day 1

  4. discharge location placement

    Time frame: 1 - 3 days on average

    home, rehab or nursing facility

Secondary outcomes

  1. Outpatient narcotic pill consumption

    Time frame: 6-week from surgery

    narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit

  2. Outpatient narcotic consumption refill needed

    Time frame: 6-week from surgery

    need for refill prescription, yes or no

  3. Outpatient narcotic consumption multiple refills needed

    Time frame: 6-week from surgery

    number of refills needed requiring provider time outside of scheduled appointment

Other outcomes

  1. Complications short term after surgery

    Time frame: 6-week from surgery

    Inpatient complications while in the hospital

  2. Complications long term after surgery

    Time frame: surgery to 1yr postoperative

    Outpatient complications seen after discharge

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2016
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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